YEARS OF EXPERIENCE: 5 YEARS, BOTH IN GENERAL AND ANY SPECIFIC INDUSTRY EXPERIENCE REQUIRED

• Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements
• Proficient of ISO 17025
• ASQ CCT or equivalent certification/education (strongly preferred)
• Quality or Lean Certifications (i.e. Six Sigma Belt, ASQ CQE)
• Prior Medical Devices Experience
• Advance English.

• Subject mtter expert responsible to write and improve Calibration procedures and equipment specification.
• Develop, write and approve calibration procedures and equipment specification for Standard equipment based on component specifications using spreadsheet, flow chart and word processing software and programming software. Perform system troubleshooting on all equipment types to the board level. Review documentation, checklists and manuals for accuracy and completeness. Perform Standard equipment validations, data analysis, measurement studies and calibration certificate analysis. Perform outside calibration supplier evaluation. Support quality investigations (OOTs, NCMR, CAPAs. etc.)
• Supervise the calibration technician as applicable